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Sinex by The Procter & Gamble Manufacturing Company

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: The Procter & Gamble Manufacturing Company
NDC Code: 37000-509

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Vicks ® Sinex™

Daytime Congestion, Pressure & Pain and Nighttime Congestion, Pressure & Pain

DAYTIME SINEX CONGESTION, PRESSURE & PAIN

Drug Facts

Active ingredients (in each LiquiCap)Purpose
Acetaminophen 325 mgPain reliever/Fever reducer
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves symptoms due to the common cold
    • minor aches and pains
    • headache
    • fever
    • nasal congestion
    • sinus congestion & pressure
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion & pressure

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • you get nervous, dizzy or sleepless

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions
  • take only as directed
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information
  • store at room temperature

Inactive ingredients

FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-873-8276

NIGHTTIME SINEX CONGESTION, PRESSURE & PAIN

Drug Facts

Active ingredients (in each LiquiCap)Purpose
Acetaminophen 325 mgPain reliever/Fever reducer
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves symptoms due to the common cold
    • minor aches and pains
    • headache
    • fever
    • runny nose and sneezing
    • nasal congestion
    • sinus congestion & pressure
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
    • minor aches and pains
    • headache
    • runny nose and sneezing
    • itching of the nose or throat, and itchy, watery eyes
    • nasal congestion
    • sinus congestion & pressure

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • to make a child sleep

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • you get nervous, dizzy or sleepless

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions
  • take only as directed
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information
  • store at room temperature

Inactive ingredients

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-873-8276

DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202.

PRINCIPAL DISPLAY PANEL - Kit Carton

FAST RELIEF
VICKS®

SINEX

DAYTIME CONGESTION, PRESSURE & PAIN

Acetaminophen-Pain Reliever,
Phenylephrine HCl-Nasal Decongestant

  • Sinus Congestion & Pressure
  • PAIN & HEADACHE

Non-Drowsy

16 DAYTIME LIQUICAPS


SINEX

NIGHTTIME CONGESTION, PRESSURE & PAIN

Acetaminophen-Pain Reliever; Doxylamine succinate-

Antihistamine; Phenylephrine HCl-Nasal Decongestant

  • Sinus Congestion & Pressure
  • PAIN & HEADACHE

8 NIGHTTIME LIQUICAPS 24 TOTAL

SINEX 
acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-509
Packaging
#Item CodePackage Description
1NDC:37000-509-241 KIT in 1 PACKAGE
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 18 BLISTER PACK 16 
Part 24 BLISTER PACK
Part 1 of 2
SINEX 
acetaminophen and phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeOVALSize21mm
FlavorImprint CodeVS;DAY
Contains    
Packaging
#Item CodePackage Description
12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2014
Part 2 of 2
SINEX 
acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
TITANIUM DIOXIDE 
Product Characteristics
ColorturquoiseScoreno score
ShapeOVALSize21mm
FlavorImprint CodeVS;NIGHT
Contains    
Packaging
#Item CodePackage Description
12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/29/2016
Labeler - The Procter & Gamble Manufacturing Company (004238200)

 
The Procter & Gamble Manufacturing Company

← See all Sinex brands

Medically reviewed on May 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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